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    IRIS 認證 關于新冠病毒(COVID-19)的溝通信

    日期:2021-07-07 17:20:44     閱讀:


    The aim of this document is to inform IRIS rev.03 certified organizations, organizations starting the IRIS Certification® process and other stakeholders that the IRIS Management Centre (IMC), in response of the outbreak of the recent coronavirus, is monitoring the situation closely and has developed and approved rules and procedures to overcome this extraordinary situation.本文件的目的是通知IRIS03已獲證組織,已開始IRIS認證進程的組織以及其他相關方,為了應對最近爆發的新冠肺炎疫情,IRIS管理中心(IMC)正密切關注疫情的發展,并制定了相關的規則和程序以共渡此非常時期。

    Due to this current situation, IRIS approved certification bodies may temporarily be unable to perform specific certification-related activities. Therefore, IMC is in close contact with the certification bodies, who themselves are the main contact point for all the affected companies. The IRIS audits are postponed for the concerned countries (see appendix) until a stable situation is back.基于目前的狀況,IRIS批準認證機構可以暫時停止與認證有關的活動,各認證機構是受影響組織的主要聯系窗口,IMC正與各認證機構保持密切溝通,附件為IRIS審核暫停國家名單,待疫情穩定后認證工作將會恢復正常。

    All the defined rules and procedures aim to ensure the continuity of the IRIS Certification® for the affected organizations and to ensure the quality of the audit process through on-site audits and finally maintain the confidence of your organization and your customer on the IRIS Certificate.所有已制定的規則和程序目的在于確保受影響組織IRIS認證的連續性,并通過現場審核的方式來確保審核質量以維護你們以及你們的客戶對IRIS認證的信心。

    Our priority are the health and safety of the involved parties, as well as the responsibility towards them and the confidence on the IRIS Certificate.我們的優先考慮是相關方的健康和安全,以及維護大家對IRIS認證的信任。

    This document represents the current status and may evolve according to the development of the disease. The IRIS Portal (www.iris-rail.org) is still the main source for any information related to this topic including updates. 本文件是基于現在的疫情狀況制定并會根據其發展進行相應調整,IRIS網站仍然是大家了解與此相關信息的首要來源。


    The precondition for the expiration date of the IRIS certificate is suspended. (IRIS Certification? rules:2017, clause 4.1.2 Certificate cycle: The expiration date of the certificate is maximum three (3) years minus one (1) day from the last day of the certification audit (reference date), under the precondition that all subsequent surveillance audits during this time are successful in meeting the requirements). 以前關于IRIS認證有效期的規定暫停(IRIS認證規則:2017,4.1.2中關于認證周期:認證有效期最多為參考日期后三年的前一天,前提是在這個周期內通過所有的有關監督審核)。

    The current audit validity is extended for 3 months (90 calendar days) for the concerned

    organizations. The extension is based on the reference date of the organization and is visible in the IRIS Portal.現在對于受影響的組織其認證有效期可延長三個月(90天),這個延長是基于其參考日期的,在IRIS網站可以查到。

    IMC is ensuring that these organizations are still visible in the IRIS Portal for the public as IRIS certified organization. IMC目的是確保這些組織仍然作為已獲證的組織可以在IRIS網站上查詢。

    For the application status, please refer to the appendix: List of countries.具體情況請見附錄的國家清單。


    Following criteria are the basis for the defined specific rules and procedures:以下為采取措施的準則:

    The reference date of each organization is the trigger for the different actions組織的參考日期為采取措施的基礎

    IRIS audits are to be performed on-site according to the IRIS Certification? rules:2017 IRIS審核仍將根據IRIS認證規則:2017的要求進行現場審核

    The different actions are managed country by country based on the evolution of this extraordinary situation每個國家可根據疫情情況采取不同的措施

    Certification bodies are responsible for the application of the rules and the support to their customers認證機構負責規則的實施以及對其顧客的支持

    IMC Official Re-Start date (IORS): is introduced as a date to restart activities according to rules defined in this document. This date is defined by the IMC country by country based on: IMC正式重啟日期(IORS)為IMC依據此 規則發布的活動重啟日期,此日期由IMC根據以下信息按照不同國家的情況發布

    ? The official acknowledged worldwide situation (World Health Organization) applied to

    the respective countries來自世衛組織的正式認可的各國疫情信息

    ? The full return to normal conditions (full operation on-site) of the whole country, without any restriction, e.g. travel bans, border closure, visa validation, …恢復正常狀況指的是整個國家沒有任何限制,如旅行禁令,邊界關閉,簽證限制等。

    Only when IMC defines the IORS for a country, the CBs can re-start the planning of the postponed audits.只有IMC確定了IORS日期,認證機構才能重啟審核策劃。

    All audit types are to be performed after 45 calendar days from the defined IORS, based on an official communication through the IRIS Portal (see appendix).所有類型的審核都應通過IRIS網站進行正式溝通,并在確定的IORS日期45天后實施。

    As described in the figure below, the IORS considers the availability of the data from the organization, which can only be provided after full operation recovery of the organization, to demonstrate the current performance. It also considers the proper preparation of the on-site audit.如下圖所示,IORS考慮了資料的獲取,資料需在組織的運營全面恢復后提交,以展示企業的現行績效,并且考慮了現場審核準備的時間。



    For countries still working under normal conditions, audits can still be performed under the responsibilities of certification bodies and the organizations. The audits are to be compliant with the IRIS Certification? rules:2017.對于那些仍然正常工作的國家,審核還可以按照IRIS認證規則:2017進行。

    Countries where the outbreak of the coronavirus is confirmed and the local restrictions are in place (no business continuity for all employees), the IRIS audits are postponed until a stable situation is back.爆發新冠疫情的國家,企業未全面恢復生產,仍然有部分限制的,IRIS審核推遲至重回穩定狀態。

    These two conditions apply to all type of audits (Certification / Surveillance / Re-certification audits) and for the assessment of the related remote locations and site extensions.這兩個條件適用于所有類型的審核(認證/監督/換證審核)以及對相關遠程支持場所和擴展地址的審核。



    For other types of audits, e.g. transfer of CB, change of location, … the application rules are described above in clause 4 “Management of IRIS audits”.對于其它類型的審核,如機構轉移,地址變更,上面第4條IRIS審核的管理規定適用。

    All other rules of the IRIS Certification? rules:2017, clause 6 “Other audits”, are maintained.所有IRIS認證規則:2017規定的其它審核,第6條“其它審核”繼續適用。


    If the auditor has identified nonconformities before the organizations’ activity stop, compliance with all the requirements for the nonconformity management process as defined in the IRIS Certification? rules:2017, clause 13 “Nonconformity management” shall be ensured.如果不合格是在組織的活動停止前審核時提出的,必須確保按照IRIS認證規則:2017第13條規定。

    For the review of the effectiveness of the corrective actions the following rules apply:不合格有效性評審規定如下:


    Table 2: Nonconformity Management based on type of non-compliance基于不合格類型的管理規定


    Audits postponed due to Covid-19 and performed after 1st May 2020 are not officially eligible for the Silver Quality Performance Level.由于新冠肺炎爆發而推遲至2020年5月1日后審核的不適用于銀牌的授予。


    The main contact for all organizations is the respective certification body.各個組織的主要聯系方式還是相應的認證機構

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